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Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2020;224(1):72.e1-72.e50doi: 10.1016/j.ajog.2020.07.032.
Al-Hendy, A., Bradley, L., Owens, C. D., Wang, H., Barnhart, K. T., Feinberg, E., Schlaff, W. D., Puscheck, E. E., Wang, A., Gillispie, V., Hurtado, S., Muneyyirci-Delale, O., Archer, D. F., Carr, B. R., Simon, J. A., & Stewart, E. A. (2021). Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. American journal of obstetrics and gynecology, 224(1), 72.e1-72.e50. https://doi.org/10.1016/j.ajog.2020.07.032
Al-Hendy, Ayman, et al. "Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids." American journal of obstetrics and gynecology vol. 224,1 (2021): 72.e1-72.e50. doi: https://doi.org/10.1016/j.ajog.2020.07.032
Al-Hendy A, Bradley L, Owens CD, Wang H, Barnhart KT, Feinberg E, Schlaff WD, Puscheck EE, Wang A, Gillispie V, Hurtado S, Muneyyirci-Delale O, Archer DF, Carr BR, Simon JA, Stewart EA. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021 Jan;224(1):72.e1-72.e50. doi: 10.1016/j.ajog.2020.07.032. Epub 2020 Jul 20. PMID: 32702363.
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Am J Obstet Gynecol. 2021 Jan;224(1):72.e1-72.e50. doi: 10.1016/j.ajog.2020.07.032. Epub 2020 Jul 20.

Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids.

American journal of obstetrics and gynecology

Ayman Al-Hendy, Linda Bradley, Charlotte D Owens, Hui Wang, Kurt T Barnhart, Eve Feinberg, William D Schlaff, Elizabeth E Puscheck, Alice Wang, Veronica Gillispie, Sandra Hurtado, Ozgul Muneyyirci-Delale, David F Archer, Bruce R Carr, James A Simon, Elizabeth A Stewart

Affiliations

  1. Department of Obstetrics and Gynecology, The University of Illinois College of Medicine, Chicago, IL. Electronic address: [email protected].
  2. Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH.
  3. Department of Obstetrics and Gynecology, AbbVie Inc, North Chicago, IL.
  4. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.
  5. Northwestern University, Chicago, IL.
  6. Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, PA.
  7. Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI.
  8. Department of Obstetrics and Gynecology, Ochsner Baptist Hospital, New Orleans, LA.
  9. Department of Obstetrics and Gynecology, University of Texas Health Center, Houston, TX.
  10. Department of Obstetrics and Gynecology, SUNY Downstate Health Science University, Brooklyn, NY.
  11. Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA.
  12. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.
  13. Department of Obstetrics and Gynecology, George Washington University, IntimMedicine Specialists, Washington, DC.
  14. Department of Obstetrics and Gynecology, Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN.

PMID: 32702363 DOI: 10.1016/j.ajog.2020.07.032

Abstract

BACKGROUND: Uterine fibroids are one of the most common neoplasms found among women globally, with a prevalence of approximately 11 million women in the United States alone. The morbidity of this common disease is significant because it is the leading cause of hysterectomy and causes significant functional impairment for women of reproductive age. Factors including age, body mass index, race, ethnicity, menstrual blood loss, fibroid location, and uterine and fibroid volume influence the incidence of fibroids and severity of symptoms. Elagolix is an oral gonadotropin-releasing hormone receptor antagonist that competitively inhibits pituitary gonadotropin-releasing hormone receptor activity and suppresses the release of gonadotropins from the pituitary gland, resulting in dose-dependent suppression of ovarian sex hormones, follicular growth, and ovulation. In Elaris Uterine Fibroids 1 and Uterine Fibroids 2, 2 replicate multicenter, double-blind, randomized, placebo-controlled, phase 3 studies, treatment of premenopausal women with elagolix with hormonal add-back therapy demonstrated reduction in heavy menstrual bleeding associated with uterine fibroids.

OBJECTIVE: This analysis aimed to evaluate the safety and efficacy of elagolix (300 mg twice a day) with add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate once a day) in reducing heavy menstrual bleeding associated with uterine fibroids in various subgroups of women over 6 months of treatment.

STUDY DESIGN: Data were pooled from Elaris Uterine Fibroid-1 and Uterine Fibroid-2 studies, which evaluated premenopausal women (18-51 years) with heavy menstrual bleeding (>80 mL menstrual blood loss per cycle, alkaline hematin methodology) and ultrasound-confirmed uterine fibroid diagnosis. Subgroups analyzed included age, body mass index, race, ethnicity, baseline menstrual blood loss, fibroid location, and uterine and primary fibroid volume (largest fibroid identified by ultrasound). The primary endpoint was the proportion of women with <80 mL menstrual blood loss during the final month and ≥50% menstrual blood loss reduction from baseline to final month. Secondary and other efficacy endpoints included mean change in menstrual blood loss from baseline to final month, amenorrhea, symptom severity, and health-related quality of life. Adverse events and other safety endpoints were monitored.

RESULTS: The overall pooled Elaris Uterine Fibroid-1 and Uterine Fibroid-2 population was typical of women with fibroids, with a mean age of 42.4 (standard deviation, 5.4) years and a mean body mass index of 33.6 (standard deviation, 7.3) kg/m

CONCLUSION: Elagolix with hormonal add-back therapy was effective in reducing heavy menstrual bleeding associated with uterine fibroids independent of age, body mass index, race, ethnicity, baseline menstrual blood loss, fibroid location, and uterine and primary fibroid volume.

Copyright © 2020 AbbVie Inc. Published by Elsevier Inc. All rights reserved.

Keywords: BMI; age; elagolix; fibroid location; fibroid volume; heavy menstrual bleeding; leiomyoma; menstrual blood loss; race; subgroups; uterine fibroid; uterine volume

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